BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AARON

    MDR report key: 224139 · Received May 10, 1999

    Report

    Report Number
    1030322-1999-00001
    Event Type
    Injury
    Date Received
    May 10, 1999
    Date of Event
    April 14, 1999
    Report Date
    May 6, 1999
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SURGEON USED A HIGH TEMPERATURE CAUTERY FOR AN OPHTHALMIC PROCEDURE THAT REQUIRED A LOW TEMPERATURE CAUTERY. THE SURGEON HAD ORDERED THE CORRECT CAUTERY, BUT HAD BEEN INCORRECTLY SUPPLIED THE HIGH TEMPERATURE BY THE HOSPITAL'S DISTRIBUTION CENTER. THERE WAS AN INJURY TO THE EYE BUT NOTHING THAT WAS PERMANENT DAMAGE. DUE TO THE INCIDENT, THE SURGERY PERFORMED TOOK LONGER TO REPAIR THE DAMAGED AREA FOR THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AARON CAUTERY GEI AARON MEDICAL INDUSTRIES NA 1096A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention